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NCT05512156
Toothbrushing Program in Saudi Arabia "TOPS"
NA trial testing Supervised Toothbrushing in Dental Caries in Children in 588 participants. Completed in 30 December 2024.
12 September 2024
Quick facts
| Lead sponsor | University of Glasgow |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 588 |
| Start date | 18 September 2022 |
| Primary completion | 12 September 2024 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across Saudi Arabia |
Drugs / interventions tested
- Supervised Toothbrushing
Conditions studied
- Dental Caries in Children — all drugs for Dental Caries in Children →
Sponsor
University of Glasgow
Who can join
Adults 42 Months to 66 Months, any sex, with Dental Caries in Children. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Project summary Introduction: Dental caries is a major oral health problem worldwide and is a particular public health challenge in Saudi Arabia. Dental caries cause pain, infection, and negatively impact quality of life. As part of population oral health improvement efforts in Saudi Arabia, this project aims to evaluate the effectiveness of a supervised toothbrushing programme in kindergartens. Aim: The aim of this project is to conduct a trial to assess the effectiveness of a supervised toothbrushing programme in kindergartens in Riyadh, Saudi Arabia . Methods: A cluster randomized controlled trial study will be undertaken in which the effectiveness of the daily supervised toothbrushing programme intervention running for two academic years will be randomly allocated to a sample of kindergartens in Riyadh and compared against treatment as usual which will be an annual oral health awareness visit in the control group of kindergartens over and above community water fluoridation. Effectiveness will be measured and delivered in terms of preventing dental caries in children when compared with children in the treatment as usual control group receiving the same level of community water fluoridation, but not the toothbrushing program intervention. All children in all kindergartens (both intervention and control groups) will have a dental examination (via trained and calibrated dental teams recording dental caries levels via dmft index) at baseline before intervention commences and at two academic years. In addition, questionnaires on behaviours and quality of life. In addition, process monitoring, and cost analysis surveys will be distributed. Research Questions: * Can such a supervised toothbrushing programme in kindergartens be effective at reducing the development of dental caries by 6 years of age? * Can a supervised toothbrushing programme in kindergartens in Saudi Arabia be established and implemented?
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Toothbrushing programme in Saudi Arabia 'TOPS': a study protocol for a cluster randomised controlled trial in kindergartens, Riyadh.
Almutairi B, Conway D, Ross A, Hattan M, et al · · 2024 · PMID 39097315 · DOI 10.1136/bmjopen-2023-083504
Verify or expand the search:
- PubMed search for NCT05512156
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05512156 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Glasgow
- Last refreshed: 27 April 2025
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